Clinical Trial of CA-4948 (Emavusertib) with Chemotherapy for Metastatic Colorectal Cancer
This study is testing a new anti-cancer drug, CA-4948 (Emavusertib), in combination with standard chemotherapy (FOLFOX plus Bevacizumab) for patients with colorectal cancer that has spread (metastatic). CA-4948 works by blocking enzymes that help cancer cells grow. The chemotherapy drugs also stop cancer cell growth in different ways. This trial aims to find the safest and most effective dose of CA-4948 when given with this chemotherapy combination. Researchers will also look at how well the treatment works against the cancer and its side effects. You may be able to join if you have confirmed metastatic colorectal adenocarcinoma that can be measured on imaging, and are at least 18 years old.
- Study design
- This is a dose-escalation study, meaning different doses of CA-4948 will be tested, followed by a dose-expansion study. It plans to enroll 24 participants.
- What's involved
- You would undergo a tumor biopsy, blood sample collections, and CT or PET/CT scans. CA-4948 is taken by mouth, and Bevacizumab is given intravenously (IV).
- Compensation
- Not stated in the trial record.
- Follow-up
- The study measures dose-limiting toxicities and adverse events for up to 2 cycles (each cycle is 14 days).
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
NCT06696768
Clinical Trial of an Anti-cancer Drug, CA-4948 (Emavusertib), in Combination With Chemotherapy Treatment (FOLFOX Plus Bevacizumab) in Metastatic Colorectal Cancer
Recruiting
PHASE1Ages 18+InterventionalTreatmentNational Cancer Institute (NCI)Government-funded
~24 participants
Updated 2026-09-09 on ClinicalTrials.gov
What's tested:BevacizumabBiopsy ProcedureBiospecimen CollectionComputed TomographyEmavusertibFluorouracil
At a glance
Recruiting sites
13 of 13 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Dose limiting toxicities (DLT)
Measured over Up to 2 cycles (Cycle length = 14 days)
+1 more outcome measured
Conditions
NCT06696768
Where you'd take part
This study runs at 13 sites. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.
Memorial Hospital East
Shiloh, Illinoisstudy coordinator listed
Recruiting
Siteman Cancer Center at Christian Hospital
St Louis, Missouristudy coordinator listed
Recruiting
Siteman Cancer Center at Saint Peters Hospital
City of Saint Peters, Missouristudy coordinator listed
Recruiting
Siteman Cancer Center at West County Hospital
Creve Coeur, Missouristudy coordinator listed
Recruiting
Siteman Cancer Center-South County
St Louis, Missouristudy coordinator listed
Recruiting
UF Health Cancer Institute - Gainesville
Gainesville, Floridastudy coordinator listed
Recruiting
University of Kansas Cancer Center
Kansas City, Kansasstudy coordinator listed
Recruiting
University of Kansas Clinical Research Center
Fairway, Kansasstudy coordinator listed
Recruiting
Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.
Study leadership
- Susanna V Ulahannan · PRINCIPAL_INVESTIGATOR · Yale University Cancer Center LAO
Who to contact
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Eligibility criteria
Inclusion
Patients must have histologically or cytologically confirmed colorectal adenocarcinoma
Patients must have unresectable or metastatic measurable disease on imaging for Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 determination within 28 days of registration
For patients enrolling to the expansion cohort, lesions must be amenable to research biopsy
Age ≥ 18 years. Because no dosing or adverse event data are currently available on the use of CA-4948 (emavusertib) and FOLFOX in combination with bevacizumab in patients \< 18 years of age, children are excluded from this study
Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2 (or Karnofsky ≥ 60%)
Absolute neutrophil count ≥ 1,500/mcL (within 28 days of registration)
Platelets ≥ 75,000/mcL (within 28 days of registration)
Total bilirubin ≤ 1.5 × institutional upper limit of normal (ULN) (within 28 days of registration)
Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase \[SGOT\])/alanine aminotransferase (ALT) (serum glutamic pyruvic transaminase \[SGPT\]) ≤ 3 × institutional ULN; for those with liver metastases, 5 × institutional ULN (within 28 days of registration)
Estimated glomerular filtration rate (eGFR) ≥ 60 mL/min/1.73 m\^2 (within 28 days of registration)
Creatine phosphokinase (CPK) elevation at screening \< grade 2 (CPK ≤ 2.5 x ULN) (within 28 days of registration)
Patients on a cholesterol lowering statin must be on a stable dose with no dose changes within 3 weeks prior to study start
Human immunodeficiency virus (HIV)-infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months are eligible for this trial
For patients with evidence of chronic hepatitis B virus (HBV) infection, the HBV viral load must be undetectable on suppressive therapy, if indicated
Patients with a history of hepatitis C virus (HCV) infection must have been treated and cured. For patients with HCV infection who are currently on treatment, they are eligible if they have an undetectable HCV viral load
Patients with treated brain metastases are eligible if follow-up brain imaging after central nervous system (CNS)-directed therapy shows no evidence of progression
Patients with new or progressive brain metastases (active brain metastases) or leptomeningeal disease are eligible, after discussion with the principal investigator (PI) or National Cancer Institute (NCI) Cancer Therapy Evaluation Program (CTEP) Investigational Drug Branch (IDB) Monitor, if the treating physician determines that immediate CNS-specific treatment is not required and is unlikely to be required during the first cycle of therapy
Patients with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen are eligible for this trial
Patients with known history or current symptoms of cardiac disease, or history of treatment with cardiotoxic agents, should have a clinical risk assessment of cardiac function using the New York Heart Association Functional Classification. To be eligible for this trial, patients should be class II or better
Patients must be able to take oral medications
The effects of CA-4948 (emavusertib) on the developing human fetus are unknown. For this reason, women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation. Women of childbearing potential must continue contraception for 9 months following the last dose of study drugs. Should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately. Males treated or enrolled on this protocol and involved with women of childbearing potential must also agree to use adequate contraception prior to the study, for the duration of study participation, and for 6 months following the last dose of study drugs
Patients must have the ability to understand and the willingness to sign a written informed consent document
Exclusion
Patients with high-frequency microsatellite instability (MSI-H) or deficient deoxyribonucleic acid (DNA) mismatch repair (dMMR) colorectal cancer at pre-enrollment screening
Patients with prolonged QT interval by Fridericia's correction formula (QTcF) (\> 450ms) on screening electrocardiogram (ECG)
Patients who have not recovered from adverse events due to prior anti-cancer therapy (i.e., have residual toxicities \> grade 1), with the exception of alopecia
Patients who are receiving any other investigational agents
Patients who have received prior treatment with any chemotherapy (either in the adjuvant or metastatic setting), including FOLFOX, fluorouracil/leucovorin/irinotecan (FOLFIRI), folinic acid/fluorouracil/oxaliplatin/irinotecan (FOLFOXIRI), or antiangiogenic agents such as bevacizumab and similar agents, are not eligible for this study
Patients with a known dihydropyrimidine dehydrogenase deficiency
Patients with a history of allergic reactions attributed to compounds of similar chemical or biologic composition to CA-4948 (emavusertib) or other agents used in the study
Patients with a gastrointestinal (GI) condition that could impair absorption of CA-4948 (emavusertib) or cause an inability to ingest CA-4948 (emavusertib)
Patients with uncontrolled intercurrent illness or any other significant condition(s) that would make participation in this protocol unreasonably hazardous
Pregnant women are excluded from this study because CA-4948 (emavusertib) is a blood-brain barrier penetrant with the potential for teratogenic or abortifacient effects. Because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with CA-4948 (emavusertib), breastfeeding should be discontinued if the mother is treated with CA-4948 (emavusertib). These potential risks may also apply to other agents used in this study. Women of childbearing potential must have a negative pregnancy test within 7 days of study registration
Patients with a history of allogeneic organ or stem cell transplantation
Patients with significant active bleeding or those in whom the treating physician believes bevacizumab would not be safe or appropriate
Patients who have had palliative radiation to bone metastases within 2 weeks prior to day 1 of the study treatment
Patients who have had a major surgical procedure within 4 weeks prior to day 1 of the study treatment
Patients with hypertension not controlled by antihypertensive medication
Treatment with systemic immunosuppressive medications (including, but not limited to, prednisone, cyclophosphamide, azathioprine, methotrexate, thalidomide, and anti-tumor necrosis factor \[anti-TNF\] agents) within 14 days prior to treatment; however,
Patients who have received acute, low dose, systemic immunosuppressant medications (e.g., a one-time dose of dexamethasone for nausea; or chronic daily treatment with corticosteroids with a dose of ≤ 10 mg/day methylprednisolone equivalent) may be enrolled
The use of inhaled corticosteroids and mineralocorticoids (e.g., fludrocortisone) for patients with orthostatic hypotension or adrenocortical insufficiency is allowed
Severe infections within 28 days prior to treatment, including but not limited to, hospitalization for complications of infection, bacteremia, or severe pneumonia. This includes receipt of oral or IV antibiotics within 14 days prior to registration. Patients receiving prophylactic antibiotics (e.g., for prevention of a urinary tract infection or chronic obstructive pulmonary disease) are eligible
What this trial measures
- Dose limiting toxicities (DLT)Up to 2 cycles (Cycle length = 14 days)
DLT will be based on the first 2 cycles (28 days) of emavusertib.
- Incidence of treatment-emergent adverse eventsUp to 2 cycles (Cycle length = 14 days)
The adverse events will be recorded by Common Terminology Criteria for Adverse Events (CTCAE) version (v) 5.0.